NaQuinate SAD/MAD
Research type
Research Study
Full title
A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF NAQUINATE IN HEALTHY VOLUNTEERS AND POST MENOPAUSAL WOMEN WITH LOW BONE MINERAL DENSITY.
IRAS ID
255075
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
Haoma Medica Ltd
Eudract number
2018-000569-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 7 days
Research summary
This is a first-in-human, Phase I, single-centre study in at least 58 healthy male and female volunteers.
The main purpose of the study is to see how safe the study drug, NaQuinate, is and how well the body tolerates it after single and repeated oral doses. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as pharmacokinetics [PK]).
The study comprises two parts. A single dose (increasing per cohort) (Part A) and repeated daily doses (increasing per cohort) over 7 days (Part B) will be given to separate cohorts (groups) of healthy male and female volunteers in a double-blind, randomised, placebo-controlled study design. Part A will be made up of up to 5 cohorts of 6 to 8 volunteers in each cohort, while Part B will be made up of up to 3 cohorts of 8 volunteers each. In Part A and B, up to 2 additional cohorts of 6 volunteers each may be investigated if required and justified from safety and PK data. In each study part, the next higher dose will only be given to the next cohort if the previous lower dose was determined as safe.
Each study part includes a screening visit, treatment period and a follow-up visit. Eligible participants in Part A and B will stay inhouse for approximately 48 hours after the last dose at the end of the treatment period.
NaQuinate is being developed by Haoma Medica, Ltd., for osteoporosis (a condition in which bones become weak and brittle) treatment.
As this is the first study with NaQuinate in humans, no human safety data is available yet. Based on the nonclinical safety data, no clinically significant undesirable effects are expected.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0127
Date of REC Opinion
17 Apr 2019
REC opinion
Favourable Opinion