Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

Phase 1

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: ALRN-5281 0.15 mg/kg; Drug: ALRN-5281 0.015 mg/kg; Drug: ALRN-5281 0.05 mg/kg; Drug: Placebo 0.015 mg/kg; Drug: Placebo 0.05mg/kg; Drug: Placebo 0.15mg/kg

• Registration Number: NCT01775358
• Lead Sponsor: Aileron Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-24
• Study First Posted: 2013-01-25
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALRN-5281 0.15 mg/kg	ALRN-5281 0.15 mg/kg	Dosage- 0.15 mg/kg
ALRN-5281 0.015 mg/kg	ALRN-5281 0.015 mg/kg	Dosage-0.015 mg/kg
ALRN-5281 0.05 mg/kg	ALRN-5281 0.05 mg/kg	Dosage- 0.05 mg/kg
Placebo 0.015 mg/kg	Placebo 0.015 mg/kg	Dosage- 0.015 mg/kg
Placebo 0.05 mg/kg	Placebo 0.05mg/kg	Dosage- 0.05 mg/kg
Placebo 0.15 mg/kg	Placebo 0.15mg/kg	Dosage - 0.15 mg/kg

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	28 days

Secondary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281	Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
Maximum plasma concentration (Cmax) of ALRN-5281	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	Predose, Day 1-Day 28
Serum GH	Predose, Day 1-Day 28
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Trial Locations

Locations (1)

Vince and Associates Clinical Research, LLC; 🇺🇸 Overland Park, Kansas, United States