Clinical trial NCT01775358: Phase 1 Safety Study of ALRN-5281 in Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Growth Hormone Deficiency
Lead sponsor: Aileron Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-25
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.


Eligibility 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 28 days
Secondary outcomes:
measure: Serum IGF-1
timeFrame: Predose, Day 1-Day 28
measure: Serum GH
timeFrame: Predose, Day 1-Day 28
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281
timeFrame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
measure: Maximum plasma concentration (Cmax) of ALRN-5281
timeFrame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research, LLC
state: Kansas
Study officials:
affiliation: Vince and Associates
name: Bradley D Vince, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aileron Therapeutics, Inc.
name: Hubert C Chen, M.D.
role: STUDY_DIRECTOR
References: