Not Yet RecruitingPhase 1

BF844 Safety and Pharmacokinetic Study in Healthy Volunteers

Australia76 participantsStarted 2024-09-09

Plain-language summary

First-in-Human Phase-1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of BF844 when Administered Orally to Healthy Adult Participants.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male or female between the ages of 18 and 45 years (inclusive) at the time of Screening. Healthy status will be determined by the Investigator based on medical history, clinical laboratory results, vital sign and electrocardiogram measurements, and physical examination at screening.
✓. Willingness and ability to give personal signed informed consent and comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
✓. Weight of at least 45 kg and a body mass index (BMI) ≥ 19.0 and ≤ 32.0 kg/m2 at Screening.
✓. Male participants who are non-sterilized and sexually active with a female partner of childbearing potential must agree to use adequate contraception from the signing of informed consent, throughout the duration of the study, and for 90 days after completion of the study. Male participants must use barrier contraception (e.g., condom). In addition to the male participant using a condom, the female partner of childbearing potential must also be using a highly effective form of contraception (hormonal or non-hormonal). The male participant must be advised and agree not to donate sperm during this period.
✓. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to routinely use highly effective contraception from signing of informed consent, throughout the duration of the study, and for 30 days after completion of the study. A highly effective method of contraception for women of childbearing potential is defined as one that has no higher than a 1% failure rate per year. The acceptable methods of contraception are:

Exclusion criteria

✕. Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
✕. Has received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
✕. Participant who is a study site employee or who is an immediate family member of a study site employee, (e.g., spouse, parent, child, sibling). Any participant under duress during the consent process.
✕. Participant has any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal (estimated or actual GFR less than 90 mL/minute), metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality, which may affect safety, or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance; however, consultation with the Sponsor and/or CRO MM may be warranted.
✕. Participant has a known hypersensitivity to any component of the formulation of BF844.
✕. Participant has a positive urine result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).
✕. Participant who, in the opinion of the Investigator, has a history of excessive alcohol or drug abuse within one year of Screening.
✕. Use of or plans to use medications (e.g., S-warfarin, NSAIDs, phenytoin, omeprazole, and clopidogrel) that are significantly metabolized by CYP2C19/ CYP2C9. Additionally, the use of any medications that could have a significant impact on organ function (e.g., barbiturates, omeprazole, and cimetidine). These drugs are prohibited during the study and within 5 half-lives of the individual agent or within 28 days (whichever is longer) prior to enrollment.

What they're measuring

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

Trial details

NCT IDNCT06592131

SponsorEyeXCel Pty. Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-06

Contact for this trial

Rachelle Kirk-Burnnand

+61 439-615-368 rachelle@basebio.com.au

View on ClinicalTrials.gov More Usher Syndrome Type 3 trials

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male or female between the ages of 18 and 45 years (inclusive) at the time of Screening. Healthy status will be determined by the Investigator based on medical history, clinical laboratory results, vital sign and electrocardiogram measurements, and physical examination at screening.
✓. Willingness and ability to give personal signed informed consent and comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
✓. Weight of at least 45 kg and a body mass index (BMI) ≥ 19.0 and ≤ 32.0 kg/m2 at Screening.
✓. Male participants who are non-sterilized and sexually active with a female partner of childbearing potential must agree to use adequate contraception from the signing of informed consent, throughout the duration of the study, and for 90 days after completion of the study. Male participants must use barrier contraception (e.g., condom). In addition to the male participant using a condom, the female partner of childbearing potential must also be using a highly effective form of contraception (hormonal or non-hormonal). The male participant must be advised and agree not to donate sperm during this period.
✓. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to routinely use highly effective contraception from signing of informed consent, throughout the duration of the study, and for 30 days after completion of the study. A highly effective method of contraception for women of childbearing potential is defined as one that has no higher than a 1% failure rate per year. The acceptable methods of contraception are:

Exclusion criteria

✕. Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
✕. Has received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
✕. Participant who is a study site employee or who is an immediate family member of a study site employee, (e.g., spouse, parent, child, sibling). Any participant under duress during the consent process.
✕. Participant has any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal (estimated or actual GFR less than 90 mL/minute), metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality, which may affect safety, or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance; however, consultation with the Sponsor and/or CRO MM may be warranted.
✕. Participant has a known hypersensitivity to any component of the formulation of BF844.
✕. Participant has a positive urine result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).
✕. Participant who, in the opinion of the Investigator, has a history of excessive alcohol or drug abuse within one year of Screening.
✕. Use of or plans to use medications (e.g., S-warfarin, NSAIDs, phenytoin, omeprazole, and clopidogrel) that are significantly metabolized by CYP2C19/ CYP2C9. Additionally, the use of any medications that could have a significant impact on organ function (e.g., barbiturates, omeprazole, and cimetidine). These drugs are prohibited during the study and within 5 half-lives of the individual agent or within 28 days (whichever is longer) prior to enrollment.

What they're measuring

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days

To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.

Timeframe: Baseline and 14 Days