Study to Evaluate Safety and Activity of Inhaled TRL1068 in Healthy Volunteers (NCT07644195)

🧪 Interventions in This Study

• TRL1068, a human monoclonal antibody (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Healthy male and non-pregnant, non-breast-feeding female subjects at between 18 and 65 years of age, inclusive, and representative of the general population
2. Normal spirometry at Screening, defined as FEV1 ≥ 80%
3. Willing and able to provide written informed consent
4. Availability for the entire duration of the study, and willingness to adhere to protocol requirements
5. In good health, as determined by lack of clinically significant abnormalities in health assessments performed at the Screening Visit, as judged by the Principal Investigator (PI) or as delegated by the PI to a physician or nurse practitioner as sub-investigator
6. Men and women of childbearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, or intrauterine device (IUD) for 28 days before Screening and for 90 days after Day 1. Men must also refrain from donating sperm from Day 1 and for 90 days after Day 1.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Celerion — Lincoln, Nebraska

📞 Contact the Study Coordinator

Phone: (650) 838-1400

Email: clinicalstudies@trellisbio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Participants will receive inhaled doses of TRL1068 or matching placebo every other day for 7 days (on Days 1, 3, 5, and 7).

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.