A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration … (NCT06674941) | Clinical Trial Compass
CompletedPhase 1
A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants
United States44 participantsStarted 2023-03-24
Plain-language summary
The primary objective of this trial are to assess the pharmacokinetics (PK) of a single subcutaneous (SC) administration of teprotumumab high-concentration formula (HCF) in healthy adult non-Japanese and Japanese participants and to assess the PK of teprotumumab delivered by syringe pump and by an injection device in non-Japanese participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Participant is a healthy male or female between the ages of 18 and 55 years, inclusive, at Screening.
✓. Participant has a body mass index between 18 and 30 kg/m\^2, inclusive, at Screening.
✓. Participant is medically healthy, with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or 12-lead ECG results at Screening, as deemed by the Principal Investigator (PI) or designee.
✓. If female of childbearing potential (including those with an onset of menopause \< 2 years prior to Screening, non-therapy-induced amenorrhea for \< 12 months prior to Screening or not surgically sterile \[absence of ovaries and/or uterus\]) must have a negative serum pregnancy test at Screening and Check-in and negative urine pregnancy tests at all protocol-specified time points (ie, prior to the teprotumumab dose and throughout participation in the Follow-up Period); female participants of childbearing potential who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, 1 of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior to Day 1 and continue for 180 days after receiving the dose of teprotumumab. Highly effective contraceptive methods (with a failure rate \< 1% per year), when used consistently and correctly, include implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner, or sexual abstinence. Abstinence should only be used as a contraceptive method if it is in line with the participant usual and preferred lifestyle. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not an acceptable method of contraception.
✓. If female, participant must agree not to donate an egg/oocyte from Day 1 until 180 days after receiving the dose of teprotumumab.
✓. If male, participant must be surgically sterile for at least 6 months prior to dosing or, if sexually active with a female partner of childbearing potential, must agree to use a barrier contraceptive method from Screening through 180 days after receiving the dose of teprotumumab.
What they're measuring
1
Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of Teprotumumab
Timeframe: Day 1 pre-dose to Day 57
2
AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Teprotumumab
Timeframe: Day 1 pre-dose to Day 57
3
Maximum Observed Serum Concentration (Cmax) of Teprotumumab
✓. If male, must agree not to donate sperm from Day 1 until 180 days after receiving the dose of teprotumumab.
✓. Participant has adequate venous access.
Exclusion criteria
✕. Participant has a history or presence of a clinically significant medical or psychiatric condition or disease, in the opinion of the PI or designee.
✕. Participant has a history of any illness that, in the opinion of the PI or designee, might confound the results of the trial or pose an additional risk to the participant due to participation in the trial.
✕. Participant has a history or presence of alcoholism (defined as \> 10 standard drinks per week, where 1 standard drink = 284 mL of full-strength \[4.9% alc/vol\] beer, 30 mL of 40% \[alc/vol\] spirit or a 100 mL glass of wine\]) or drug abuse within the 6 months prior to Day 1 dosing.
✕. Participant has a history or presence of hypersensitivity or idiosyncratic reaction to components of teprotumumab or prior hypersensitivity reactions to a monoclonal antibody or history.