CompletedPhase 1

A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants

New Zealand42 participantsStarted 2017-09-07

Plain-language summary

This is a Phase 1 first-in-human (FIH) study evaluating single and multiple dose administration of AL-034 in healthy adult participants. The aim is to examine the safety (including pharmacodynamic \[PD\] biomarker assessments), tolerability, and pharmacokinetics (PK) of increasing single ascending doses (SADs) (Part 1) and multiple ascending doses (MADs) (Part 2) of AL-034. The potential food effect will be investigated in healthy adult participants at one or optionally 2 single dose level(s).

Who can participate

Age range18 Years – 55 Years

SexALL

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

INCLUSION CRITERIA Each potential participant must satisfy all of the following criteria to be enrolled in the study * participant must be a man or a woman between 18 and 55 years of age, extremes included * Female participant must be of non-childbearing potential, defined as: a) Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical explanation. A high follicle stimulating hormone (FSH) level (greater than \[\>\]40 international unit per liter \[IU/L\] or milli international unit per milliliter \[mIU/mL\]) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, 2 FSH measurements will have to be taken at least 3 months apart, OR b) Permanently sterile - permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy Male participants must either: a) be surgically sterile (have had a vasectomy), or otherwise incapable of fathering a child, OR b) if heterosexually active, have a partner who is postmenopausal (as defined above), permanently sterile (as defined above), or otherwise incapable of becoming pregnant, OR c) if heterosexually active with a woman of childbearing potential, agree to use effective methods of contraception as detailed in Prohibitions and Restrictions section, from screening onwards…

What they're measuring

Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants With AEs by Severity

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants With AEs by Severity

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants with Clinically Significant Changes in Physical Examination

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants with Clinically Significant Changes in Physical Examination

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants with Vital Sign Abnormalities

Timeframe: Approximately up to 9 weeks

Trial details

NCT IDNCT03285620

SponsorAlios Biopharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-14

View on ClinicalTrials.gov More Hepatitis B trials

Plain-language summary

Who can participate

Age range18 Years – 55 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.

What they're measuring

Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants With AEs by Severity

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants With AEs by Severity

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants with Clinically Significant Changes in Physical Examination

Timeframe: Approximately up to 9 weeks

Part 2: Number of Participants with Clinically Significant Changes in Physical Examination

Timeframe: Approximately up to 12 weeks

Part 1: Number of Participants with Vital Sign Abnormalities

Timeframe: Approximately up to 9 weeks