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Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01775358
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Aileron Therapeutics

January 17, 2013
January 25, 2013
May 30, 2013
January 2013
May 2013   (Final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT01775358 on ClinicalTrials.gov Archive Site
  • Serum IGF-1 [ Time Frame: Predose, Day 1-Day 28 ]
  • Serum GH [ Time Frame: Predose, Day 1-Day 28 ]
  • 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 ]
  • 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 ]
  • 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)
Same as current
Not Provided
Not Provided
 
Phase 1 Safety Study of ALRN-5281 in Healthy Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Growth Hormone Deficiency
  • 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
  • Experimental: ALRN-5281 0.015 mg/kg
    Dosage-0.015 mg/kg
    Intervention: Drug: ALRN-5281 0.015 mg/kg
  • Experimental: ALRN-5281 0.05 mg/kg
    Dosage- 0.05 mg/kg
    Intervention: Drug: ALRN-5281 0.05 mg/kg
  • Experimental: ALRN-5281 0.15 mg/kg
    Dosage- 0.15 mg/kg
    Intervention: Drug: ALRN-5281 0.15 mg/kg
  • Placebo Comparator: Placebo 0.015 mg/kg
    Dosage- 0.015 mg/kg
    Intervention: Drug: Placebo 0.015 mg/kg
  • Placebo Comparator: Placebo 0.05 mg/kg
    Dosage- 0.05 mg/kg
    Intervention: Drug: Placebo 0.05mg/kg
  • Placebo Comparator: Placebo 0.15 mg/kg
    Dosage - 0.15 mg/kg
    Intervention: Drug: Placebo 0.15mg/kg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
48
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01775358
ALRN-100-01
No
Not Provided
Not Provided
Aileron Therapeutics
Aileron Therapeutics
Not Provided
Principal Investigator: Bradley D Vince, D.O. Vince and Associates
Study Director: Hubert C Chen, M.D. Aileron Therapeutics
Aileron Therapeutics
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP