Webinar Series on Demystifying Phases in Clinical Trials & COVID-19 Updates organized by Institute for Clinical Research (ICR), NIH Speaker: Dr. Alan Fong Yean Yip, Consultant Cardiologist & CRC head of Sarawak General Hospital and Mr. Chew Chun Keat, Technical Head of Centre for Clinical Trial, ICR More information please visit: https://clinupcovid.mailerpage.com/resources/r0x8r9-webinar-series-on-demystifying-cl

1. Introduction and Malaysia’s Experience
in Phase 1 Clinical Trials
Dr. Alan Fong FRCP & Mr. Chew Chun Keat MCRM

2. Disclaimer
•This slide was prepared for the Webinar Series Demystifying
Clinical Trials & COVID-19 Updates session on 14th July 2021, by
Dr Alan Fong, Head of Clinical Research Centre, Sarawak General
Hospital, and Mr Chew CK, Institute for Clinical Research,
Malaysia.
•This is intended to share within healthcare professionals, not for
public.
•Kindly acknowledge “Clinical Updates in COVID-19
http://www.nih.gov.my/covid-19” should you plan to share the
information obtained from this slide with your colleagues.

3. Outline
•Drug Discovery and
Development Overview
•Phase 1 Clinical Trial
•Ravida® Drug Development

4. Stages of Drug Development
To develop ONE
successful
medicine, it can
take:
•Testing of 10k
drug candidates
•Over a decade
•Over 1 billion
dollars

5. Phase 1 Clinical Trial
Reference: US FDA: Step 3 Clinical Research [Internet]. USA: US FDA: 2018 [updated 2018 Apr 01; cited 2021 Jul 9]. Available
from: https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
Graphics by Institute for Clinical Research (ICR), Ministry of Health Malaysia.

6. The Types of Phase 1 Trial Design

7. Examples of Phase 1 Trial Planning

8. Development of Malaysian Phase 1
Clinical Trial Guidelines
P1RP - Phase I
Clinical Trial
Guideline
Working Group,
20 May 2016
Malaysian
Phase 1 Clinical
Trial Guidelines
Launching
Event, 2 Nov
2017
Sources: https://clinicalresearch.my/wp-content/uploads/2020/11/Malaysian-Phase-I-Clinical-Trial-Guidelines.pdf

9. Regulatory Guideline on Phase 1 Unit
Accreditation
National Pharmaceutical Regulatory
Agency (NPRA) released the
Malaysian Guideline for Phase 1 Unit
Inspection & Accreditation in June
2018
Sources:
https://www.npra.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/MALAYSIANGUIDELINEFORPHASEIUNITINSPECTION.pdf

10. National Healthy Research Volunteer
Register (nhrvr.crc.gov.my)
• Web-based platform launched
on 2 Jul 2021
• To protect healthy volunteers’
safety by ensuring
participation between trials
are sufficiently spaced out.

11. Phase 1 Clinical Trials in Malaysia
•49 registered
Phase 1 clinical
trial in
clinicaltrials.gov
•29 completed
•12 recruiting
Sources: www.clinicaltrials.gov

12. Phase 1 Clinical Trials in Malaysia

13. Ravidasvir: From Phase 1 trial to
translational research – an accessible
Hepatitis C treatment
•Developed through South-South
collaboration between Malaysia
and Egypt, in partnership with
NGOs: Drugs for Neglected
Diseases Initiative (DNDi) and
Médecins Sans Frontières
(Doctors Without Borders)
Image courtesy of Drugs for Neglected Diseases Initiative
(DNDi)

14. Sources: www.clinicaltrials.gov
Ravida® Drug Development Layout

15. Pharmacokinetic Study
•A Phase 1 Bioequivalence Study of a Test Tablet Formulation
of Ravidasvir With the Reference Tablet Formulation of
Ravidasvir Study
•Ravidasvir formulation produced by Doppel (T) vs Ravidasvir
formulation produced by EEPI (R)
•Sample size = 36
•Study design = A Phase 1, Open-Label, Four-Period,
Two-Sequence, Two-Treatment, Single Dose, Randomized,
Crossover Bioequivalence Study

16. A Phase 1, Open-Label, Four-Period,
Two-Sequence, Two-Treatment, Single Dose,
Randomized, Crossover Bioequivalence Study
Period 2
Period 3
Period 4
Period 1
200 mg
n = 36
Fasting
Ravidasvir
(Doppel)
Ravidasvir
(EEPI)
Randomization
Post
Study
Safety
Assessment
Period 1 Period 3
Period 2 Period 4
Washout
Period
7 days
Washout
Period
7 days
Washout
Period
7 days

17. Ravida® Drug Development Layout

18. •Excellent results of Ravida in the stage 1 of the phase 3 trial (97%
cure rate)

19. Sources:
https://kpkesihatan.com/2021/06/04/kenyataan-akhbar-kpk-4-jun-2021-kelulusan-pendaftaran-secara-bersyarat-ravidasvir-200mg-tablet-bagi-
rawatan-hepatitis-c/
Malaysia became the first country to
grant conditional approval for Ravida