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A First-Time-in-Human Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects

NCT01052493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-02-12

Study results available
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Summary

When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as "Pancreatic Polypeptide" (PP). We have previously shown that injections of human PP reduces appetite and food intake. We have now developed a very similar chemical, PP 1420, as a treatment for obesity. PP 1420 has been tested in animals and has been shown to be safe, and to reduce their appetite. This study will test PP 1420 for its safety and tolerability in humans.

Conditions

Interventions

DRUG

PP 1420

Single dose of PP 1420, administered subcutaneously at either 2mg, 4mg or 8mg.

DRUG

Placebo

0.9% saline

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Stephen Bloom FRCP DSc, MB BChir · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-10-18
Completion
2010-10-18

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01052493 on ClinicalTrials.gov