Investigational Site Number: 5280001
Leiden, 2333, Netherlands
Location status: Recruiting
NCT Number: NCT07629336
SAD20411 is a single-center, first-in-human, double-blind, randomized, placebo-controlled, sequential single ascending dose study in healthy male and/or female participants with a pilot food effect investigation.
MAD20412 is a single-center, double-blind, randomized, placebo-controlled, sequential multiple ascending dose study in healthy male and/or female participants.
MAD24339 is an open-label, sequential multiple ascending dose study in hidradenitis suppurativa (HS) male and/or female participants.
Number of participants - The total expected number of healthy participants is approximately 94 and the total number of HS participants is expected to be approximately 20.
* SAD20411 will enroll up to 46 participants * MAD20412 will enroll up to 48 participants * MAD24339 will enroll up to 20 participants
Duration of study - The anticipated study duration per participant is up to approximately 10 weeks in SAD20411 and MAD20412, and up to approximately 12 weeks in MAD24339.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Leiden, 2333, Netherlands
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For participation in SAD20411/MAD20412:
For participation in MAD24339:
Exclusion criteria
For participation in SAD20411/MAD20412:
For participation in MAD24339:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Pharmaceutical form: Tablet Route of administration: Oral
Other names: KT-485
Pharmaceutical form: Tablet Route of administration: Oral
Time frame: Day 1 to Day 15
Time frame: Day 1 to Day 15
Time frame: Day 1 to Day 15
Time frame: Day 1 to Day 15
Time frame: Day 1 to Dat 29
Time frame: Day 1 to Dat 29
Time frame: Day 1 to Dat 29
Time frame: Day 1 to Dat 29
Time frame: Day 1 to Day 42
Time frame: Day 1 to Day 42
Time frame: Day 1 to Day 42
Time frame: Day 1 to Day 42
Time frame: Day 1 to Day 15
Maximum serum concentration observed.
Time frame: Day 1 to Day 15
Time to reach Cmax.
Time frame: Day 1 to Day 15
Area under the plasma concentration versus time curve extrapolated to infinity.
Time frame: Day 1 to Day 15
Maximum serum concentration observed.
Time frame: Day 1 to Day 15
Time to reach Cmax.
Time frame: Day 1 to Day 15
Area under the plasma concentration versus time curve extrapolated to infinity.
Time frame: Day 1 to Dat 29
Maximum serum concentration observed.
Time frame: Day 1 to Dat 29
Time to reach Cmax.
Time frame: Day 1 to Dat 29
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval
Time frame: Day 1 to Day 42
Time frame: Day 1 to Day 42
Contact information is provided by the study sponsor or research team.
Sanofi
Industry
A Randomized, First-in-human, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses (SAD20411) and Multiple Ascending Doses (MAD20412) of SAR447971 With Food Effect Evaluation in Healthy Participants and of Multiple Ascending Doses (MAD24339) of SAR447971 in Patients With Hidradenitis Suppurativa
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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