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Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Molgramostim When Administered by Inhalation to Healthy Adult Subjects

NCT02468908•Savara Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy, adult, male or female, 18- 55 years of age, inclusive, at screening.
•2. Life-long non smoker who has not used nicotine containing products.
•3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
•4. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, spirometry, vital signs, or ECGs, as deemed by the PI.
•5. 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:
•* hysteroscopic sterilization;
•* bilateral tubal ligation or bilateral salpingectomy;
•* hysterectomy;
•* bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to dosing in Part 1 or prior to the first dose in Part 2, and FSH serum levels consistent with postmenopausal status as per PI's judgment.
•6. 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).
+2 more criteria

Exclusion Criteria

•1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
•2. History or presence of clinically significant medical condition(s) (including ongoing active infections) or psychiatric condition(s) or disease(s) in the opinion of the PI.
•3. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
•4. Abnormal spirometry test results, in the opinion of the PI.
•5. History of severe or unexplained adverse reactions during aerosol delivery of any medicinal product.
•6. History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
•7. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim or to related compounds (i.e., Growgen®, Leucomax®, Leukine®, Topleucon™).
•8. Clinically significant history or presence of ECG abnormalities such as second- or third degree atrioventricular block, evidence, or family history of prolonged QT syndrome.
•9. Allergy to bandaids, adhesive dressing, or medical tape.
•10. Positive urine drug at screening or check in.
+15 more criteria

Locations (1)

Celerion

Belfast, United Kingdom

Key Dates

Start Date

May 1, 2015

Primary Completion Date

October 1, 2015

Completion Date

October 1, 2015

Last Updated

February 23, 2017

Enrollment

ACTUAL participants

Conditions

Pulmonary Alveolar ProteinosisBronchiectasisCystic FibrosisAcute Respiratory Distress Syndrome

Interventions

Molgramostim

DRUG

Placebo

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITING

A National Registry For Pulmonary Alveolar Proteinosis

NCT02461615

Pulmonary Alveolar Proteinosis

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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