Pilot Clinical Study, British American Hospital, Lima, Peru 2002
Objective: To investigate the
clinical efficacy, safety, tolerability, and toxicity profile of a
metabolically stable antifolate, CH-1504, compared to methotrexate
(MTX) in the treatment of rheumatoid arthritis (RA). Methods: A 24-week open-label trial
of MTX and CH-1504 was performed in 20 patients with RA. Results: Improvements in clinical
and laboratory indicators were observed in both study groups. Improvement
in the CH-1504 group was greater than in the MTX group. Both treatments
were generally well tolerated; however, the liver function test abnormalities
and gastrointestinal related adverse events expected with this class
of medication were not seen with CH-1504. Conclusion: CH-1504 appears to
be clinically efficacious and may possess a superior safety and tolerance
profile compared to MTX. (J Rheumatol 2006;33:862–4)
Phase I, Guy’s Hospital, London, United Kingdom, 2005
Phase Ia, Single Ascending Dose Objective: To evaluate the
safety, tolerability, and pharmacokinetics of escalating single oral
doses of CH-1504 in healthy male volunteers. Methods: The study was a randomized,
double-blind, placebo-controlled evaluation including 30 subjects in
6 cohorts Results: No clinically significant
alterations were seen at any of the dose levels tested. Conclusion: Pharmacokinetic data
from this trial suggest that CH-1504 is suitable for daily administration
at dosage levels that are predicted to be therapeutically effective.
Phase Ib, Multiple Ascending Dose Objective: To evaluate the
safety, tolerability, and pharmacokinetics of multiple ascending
oral doses of CH-1504 in healthy male volunteers. Methods: The study was a randomized,
double-blind, placebo-controlled evaluation conducted including 24 volunteers
in 3 cohorts of 8 subject. Results: No clinically significant
abnormalities observed at any of the dose levels tested. Conclusion: Pharmacokinetic data from
this trial suggest that CH-1504 is suitable for daily administration at dosage
levels that are predicted to be therapeutically effective and suitable for
daily administration.
