Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01775358
• Date of registration: 17/01/2013
• Prospective Registration: No
• Primary sponsor: Aileron Therapeutics
• Public title: Phase 1 Safety Study of ALRN-5281 in Healthy Subjects
• Scientific title: A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection in Healthy Adult Volunteers
• Date of first enrolment: January 2013
• Target sample size: 33
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01775358
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bradley D Vince, D.O.
• Affiliation: Vince and Associates

• Name: Hubert C Chen, M.D.
• Affiliation: Aileron Therapeutics

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of
informed consent.

2. Subjects must be in good health as determined by the Investigator based on detailed
medical history, physical examination, vital signs, clinical laboratory tests, ECGs
and other screening evaluations.

3. Ability to provide written informed consent and complying with all study requirements
and restrictions.

4. Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening

Exclusion Criteria:

1. History or current evidence of any clinically significant cardiac, endocrinologic,
hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic,
dermatologic, psychiatric, renal, or other major disease, as determined by the
Investigator

2. Previous treatment with any GH Releasing Hormone (GHRH) analog.

3. Participation in another clinical trial or treatment with an investigational agent
within 30 days or 5 half-lives, whichever is longer, prior to enrollment.

4. History of cancer within the past five years (excluding non-melanoma skin cancer).

5. History of alcohol or drug abuse or dependence within 12 months of screening as
determined by the Investigator.

6. Subjects with a body weight > 120 kg.



Age minimum: 20 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: ALRN-5281 0.015 mg/kg

Drug: ALRN-5281 0.05 mg/kg

Drug: ALRN-5281 0.15 mg/kg

Drug: Placebo 0.015 mg/kg

Drug: Placebo 0.05mg/kg

Drug: Placebo 0.15mg/kg

Primary Outcome(s)

Incidence of adverse events [Time Frame: 28 days]

Secondary Outcome(s)

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [Time Frame: Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14]

Maximum plasma concentration (Cmax) of ALRN-5281 [Time Frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14]

Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281 [Time Frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14]

Serum IGF-1 [Time Frame: Predose, Day 1-Day 28]

Serum GH [Time Frame: Predose, Day 1-Day 28]

Secondary ID(s)

ALRN-100-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors