NCT01775358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

January 17, 2013

Last Update Submit

May 29, 2013

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    28 days

Secondary Outcomes (5)

  • 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

Study Arms (6)

ALRN-5281 0.015 mg/kg

EXPERIMENTAL

Dosage-0.015 mg/kg

Drug: ALRN-5281 0.015 mg/kg

ALRN-5281 0.05 mg/kg

EXPERIMENTAL

Dosage- 0.05 mg/kg

Drug: ALRN-5281 0.05 mg/kg

ALRN-5281 0.15 mg/kg

EXPERIMENTAL

Dosage- 0.15 mg/kg

Drug: ALRN-5281 0.15 mg/kg

Placebo 0.015 mg/kg

PLACEBO COMPARATOR

Dosage- 0.015 mg/kg

Drug: Placebo 0.015 mg/kg

Placebo 0.05 mg/kg

PLACEBO COMPARATOR

Dosage- 0.05 mg/kg

Drug: Placebo 0.05mg/kg

Placebo 0.15 mg/kg

PLACEBO COMPARATOR

Dosage - 0.15 mg/kg

Drug: Placebo 0.15mg/kg

Interventions

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

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vince and Associates Clinical Research, LLC

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Bradley D Vince, D.O.

    Vince and Associates

    PRINCIPAL INVESTIGATOR

  • Hubert C Chen, M.D.

    Aileron Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 25, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

US(1)