Single Ascending Dose Tolerability Study of DG3173

NCT02217488 | Completed Phase 1

• 1 other identifier: DG3173-I-001
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial investigated the safety, tolerability and pharmacokinetic profile of DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1 study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via single dose subcutaneous injection.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of serious adverse events or withdrawals due to adverse events

  One week

Study Arms (2)

DG3173

EXPERIMENTAL

Drug: DG3173

Vehicle

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DG3173 DRUG

DG3173

Placebo DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ethnic origine: Caucasian
• Weight: 55-95 kg
• BMI: 19-29 kg/qm
• Medical history without clinically relevant pathologies
• Physical examination parameters and lung function without signs of clinically relevant pathologies
• Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) \<440ms
• Values for hematology, biochemistry and for coagulation tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the medical investigator (in particular normal values for ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, alpha-amylase and bilirubin)
• Having given written informed consent before any study-related activities are carried out

You may not qualify if:

• Evidence of clinically relevant pathology or disease
• Any history of moderate or severe hypertension, hypotension or orthostatic hypotension
• Mental handicap
• Legal incapacity
• Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
• Chronic diarrhea or other chronic gastrointestinal disorders
• Acute or chronic gastro-duodenal ulcers
• Presence or history of endocrine disorders
• Presence or history of gall stone disease, presence excluded by means of upper abdominal ultrasound
• Known hypersensitivity to the study drug or constituent of the study drug
• History of any relevant allergy, especially drug and/or food allergies
• Strict vegetarian
• Regular treatment with medications during three months prior to randomization
• Receipt of any prescription or non-prescription medication, including multi-vitamin preparations within 14 days prior to drug administration and for the duration of the study
• Use of St. John´s Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization

Sponsors & Collaborators

• Aspireo Pharmaceuticals Limited: lead
• DeveloGen AG, Germany: collaborator

MeSH Terms

Interventions

PTR 3173

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: May 1, 2008
• Primary Completion: September 1, 2008
• Last Updated: August 15, 2014

Record last verified: 2014-08