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Completed

NCT Number: NCT01775358

Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vince and Associates Clinical Research, LLC

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

  1. Incidence of adverse events

    Time frame: 28 days

Secondary outcomes

  1. Serum IGF-1

    Time frame: Predose, Day 1-Day 28

  2. Serum GH

    Time frame: Predose, Day 1-Day 28

  3. 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

  4. 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

  5. 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

    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Sponsors and collaborators

Lead sponsor

Aileron Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2013
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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