NCT01775358

Completed

Phase 1

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

Aileron Therapeutics, Inc.1 site in 1 country33 target enrollmentJanuary 2013

InterventionsALRN-5281 0.015 mg/kg ALRN-5281 0.05 mg/kg ALRN-5281 0.15 mg/kg Placebo 0.015 mg/kg Placebo 0.05mg/kg Placebo 0.15mg/kg

DrugsALRN-5281 0.015 mg/kg ALRN-5281 0.05 mg/kg ALRN-5281 0.15 mg/kg Placebo 0.015 mg/kg Placebo 0.05mg/kg Placebo 0.15mg/kg

Overview

Phase: Phase 1
Intervention: ALRN-5281 0.015 mg/kg
Conditions: Growth Hormone Deficiency
Sponsor: Aileron Therapeutics, Inc.
Enrollment: 33
Locations: 1
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

May 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Aileron Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
•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.
•Ability to provide written informed consent and complying with all study requirements and restrictions.
•Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening

Exclusion Criteria

•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
•Previous treatment with any GH Releasing Hormone (GHRH) analog.
•Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
•History of cancer within the past five years (excluding non-melanoma skin cancer).
•History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
•Subjects with a body weight \> 120 kg.

Arms & Interventions

ALRN-5281 0.015 mg/kg

Dosage-0.015 mg/kg

Intervention: ALRN-5281 0.015 mg/kg

ALRN-5281 0.05 mg/kg

Dosage- 0.05 mg/kg

Intervention: ALRN-5281 0.05 mg/kg

ALRN-5281 0.15 mg/kg

Dosage- 0.15 mg/kg

Intervention: ALRN-5281 0.15 mg/kg

Placebo 0.015 mg/kg

Dosage- 0.015 mg/kg

Intervention: Placebo 0.015 mg/kg

Placebo 0.05 mg/kg

Dosage- 0.05 mg/kg

Intervention: Placebo 0.05mg/kg

Placebo 0.15 mg/kg

Dosage - 0.15 mg/kg

Intervention: Placebo 0.15mg/kg

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: 28 days

Secondary Outcomes

Serum IGF-1(Predose, Day 1-Day 28)
Serum GH(Predose, Day 1-Day 28)
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)
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)