A phase 1, partially blind, placebo-controlled, ascending single and multiple oral dose, safety, tolerability, pharmacokinetic and pharmacodynamic study in healthy subjects and osteoarthritis patients administered APPA-1

Phase 1

Completed

• Conditions: Osteoarthritis; Musculoskeletal Diseases; Arthrosis

• Registration Number: ISRCTN13784998
• Lead Sponsor: Research Support Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-30
• Study Completion: 2019-07-31
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Part A:
1. Written informed consent
2. Between 18 and 75 years of age, inclusive
3. Of any ethnic origin
4. Healthy male subjects (groups A1 to A4)
5. Healthy female subjects (group A5)
6. BMI between 18.0 to 35.0 kg/m2
7. In good health as defined by medical history (including confirmation from GP), physical examination, vital signs assessment, 12 lead ECG and clinical laboratory evaluation.

Part B:
1. Written informed consent
2. Between 18 and 75 years of age inclusive
3. Of any ethnic origin
4. Male or female subjects with a diagnosis of osteoarthritis fulfilling the American College of Rheumatology (ACR) criteria for diagnosis
5. BMI between 18.0 to 35.0 kg/m2

Exclusion Criteria

Part A & B:
1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception or to refrain from donating sperm from the time of dosing until the Follow Up Visit.
2. Female of childbearing potential not in agreement to use two highly effective methods of contraception, or to refrain from donating ova, from the time of screening until the Follow Up Visit
3. Donated blood in the 3 months prior to screening, plasma in the 7 days prior to screening, platelets in the 6 weeks prior to screening
4. Consume more than 28 units of alcohol per week if male, or 21 units of alcohol per week if female or any significant history of alcohol / substance misuse as determined by the investigator
5. Unwilling to abstain from vigorous exercise for 48 hours prior to any study visit
6. Unwilling to abstain from alcohol for 48 hours prior to any study visit
7. Received any medication, including St John’s Wort, known to chronically alter drug absorption or elimination within 30 days prior to first dose administration unless in the opinion of the investigator it will not interfere with study procedures or compromise safety
8. Subjects who have any abnormality of vital signs prior to the first dose administration that, in the opinion of the investigator, would increase the risk of participating in the study
9. Subjects who have any clinically significant abnormal physical examination finding
10. Subjects who have any clinically significant 12 lead ECG abnormality that, in the opinion of the investigator, would increase the risk of participating in the study
11. Subjects who have any clinically significant allergy or allergic condition as determined by the investigator (with the exception of non-active hay fever)
12. Subjects who have any clinically significant abnormal laboratory safety results as determined by the investigator with specific exclusions of any AST or ALT greater than or equal to 1.5 times ULN at screening or day -1; total bilirubin > ULN (Gilbert’s syndrome is acceptable)
13. Subjects who have hepatitis B or C or are carriers of HBsAg or are carriers of HCV Ab or are positive for HIV 1/2 antibodies.
14. Subjects who have a positive alcohol breath test or a positive urine drug screen ( a repeat assessment is acceptable)
15. Subjects who are still participating in another clinical study or who have participated in a clinical study involving administration of an investigational product in the 3 months (or 5 half-lives, whichever is longer) prior to first dose administration
16. Subjects who have previously received APPA or its constituent parts within 3 months of receiving first dose.
17. Subjects who, in the opinion of the investigator, should not participate in this study.
18. Tobacco smoking within last 30 days, including use of e-cigarettes and not willing to abstain from smoking until after study involvement.

Part A exclusions only:
1. Female subjects who are pregnant or currently lactating
2. Received any prescribed systemic or topical medication within 14 days prior to the first dose administration (with the exception of the OCP)

Study & Design

• Study Type: Interventional
• Study Design: Not specified