CompletedPhase 1

Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

United Kingdom42 participantsStarted 2015-05

Plain-language summary

This is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male and female subjects (on non-child bearing potential) will be enrolled to investigate single inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The Clinical trial will involve 42 healthy participants. The trial is expected to last approximately 4 months.

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

✓. Healthy, adult, male or female, 18- 55 years of age, inclusive, at screening.
✓. Life-long non smoker who has not used nicotine containing products.
✓. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
✓. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, spirometry, vital signs, or ECGs, as deemed by the PI.
✓. Females must be of non-child bearing potential who must have undergone one of the following sterilization procedures at least 6 months prior to dosing in Part 1 or prior to the first dose in Part 2:
✓. A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non vasectomized male).
✓. If male must agree not to donate sperm from dosing in Part 1 or from the first dose in Part 2, until 90 days following last dose.
✓. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

What they're measuring

Number and severity of treatment-emergent Adverse Events (AEs) following single and multiple inhaled doses of molgramostim

Timeframe: 1-6 days

Trial details

NCT IDNCT02468908

SponsorSavara Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10

View on ClinicalTrials.gov More Pulmonary Alveolar Proteinosis 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.

Inclusion criteria

✓. Healthy, adult, male or female, 18- 55 years of age, inclusive, at screening.
✓. Life-long non smoker who has not used nicotine containing products.
✓. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
✓. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, spirometry, vital signs, or ECGs, as deemed by the PI.
✓. Females must be of non-child bearing potential who must have undergone one of the following sterilization procedures at least 6 months prior to dosing in Part 1 or prior to the first dose in Part 2:
✓. A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non vasectomized male).
✓. If male must agree not to donate sperm from dosing in Part 1 or from the first dose in Part 2, until 90 days following last dose.
✓. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria