A Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults

NCT07149831 | Recruiting Phase 1

• 1 other identifier: XTR020-101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Flotufolastat F-18 Injection is a positron emission tomography (PET) imaging tracer that targets the extracellular domain of prostate-specific membrane antigen (PSMA). This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of Flotufolastat F-18 Injection in 6 healthy elderly Chinese volunteers.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults. (%ID)

  Radioactive accumulation (%ID) in target organs following administration of Flotufolastat F-18 Injection.

  Day 1

• To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults.

  Standardized uptake value (SUV) in target organs following administration of Flotufolastat F-18 Injection.

  Day 1

Secondary Outcomes (4)

• To assess the radiation dosimetry of Flotufolastat F-18 Injection

  Day 1

• To evaluate the pharmacokinetic of Flotufolastat F-18 Injection

  Day 1

• Proportions of radioactive parent compound in plasma

  Day 1

• To evaluate the safety profile of Flotufolastat F-18 Injection

  Day 2

Study Arms (1)

Flotufolastat F-18 Injection

EXPERIMENTAL

Single dose 5.47\~6.69mCi mCi intravenous injection of Flotufolastat F-18 Injection

Drug: Flotufolastat F-18 Injection

Interventions

Flotufolastat F-18 Injection DRUG

Single dose intravenous injection of Flotufolastat F-18 Injection . Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics.

Flotufolastat F-18 Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have the ability to understand the content of study and voluntarily sign the informed consent form.
• Healthy male or female, aged 18-60 (included).
• Body mass index (BMI) between 19 and 26 kg/m² (included).
• Vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray (posterior-anterior view), and abdominal ultrasound are normal, or any abnormalities that are diagnosed clinically insignificant.
• Clinical laboratory test results are within normal ranges or any abnormalities that are diagnosed clinically insignificant.
• Have the ability to communicate effectively with the investigator and comply with the study requirement to follow-up.
• Female subject shouldcontracept effectively during the study period and 6 months after the study completed (effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or partner vasectomy). Male subject should agree to use contraception during the study period and 6 months after the study completed.

You may not qualify if:

• Claustrophobia or inability to tolerate imaging examinations for any other reason.
• Have a history of epilepsy or seizures, excluding childhood febrile seizures.
• With chronic diseases, including but not limited to:
• cardiovascular, respiratory, gastrointestinal, urinary, hematological disease, neurological, endocrine, metabolic, or musculoskeletal diseases, or a history thereof.
• history of psychiatric disorders or currently significant psychiatric conditions
• Have a history of asthma or allergies.
• Have a history of malignant tumors.
• Present any condition that may interfere with the absorption or metabolism of the investigational drug, or that may affect study results, as determined by the investigator to be clinically significant.
• Underwent any surgical procedure within 3 months before administration or planned surgery during the study period.
• Accomplished the blood donation or significant blood loss (\>400 mL) within 3 months before administration or during the screening period.
• Insufficient venous access (two distinct venous lines are required for investigational drug administration and PK sampling).
• Known allergy to the active ingredient or any excipients of the investigational product.
• Took any medications, including prescription, over-the-counter drugs, or herbal remedies, within 14 days before administration.
• Participated any other new drug's clinical trial within 4 weeks prior to the administration or within 5 half-lives of the investigating drug (whichever is longer).
• Radiopharmaceutical imaging or treatment within 7 days prior to screening or within 5 half-lives of the radiopharmaceutical (whichever is longer).

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100089, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Ruimin Wang, Doctor

CONTACT

010-66938008; wrm@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: September 2, 2025
• Study Start: June 7, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)