Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis

Inclusion Criteria:

• The participant has given written informed consent to participate.

• The participant is 18 years of age or older at the Screening Visit.

• The participant has a diagnosis of osteoarthritis of the knee based on AmericanCollege of Rheumatology criteria and functional capacity class of I to III.

• There is a documented history indicating that participant has insufficient painrelief with previous Standard of Care.

Exclusion Criteria:

• The participant has past joint replacement surgery of the index knee.

• The participant has a history of significant trauma or surgery (e.g., open orarthroscopic) to the index knee within 12 months of Screening.

• The participant has periarticular pain from any cause other than osteoarthritis,including referred pain, bursitis, or tendonitis.

• The participant has clinical hip osteoarthritis on the side of the index knee.

• The participant has pre-existing osteonecrosis, subchondral insufficiency fracture,atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributableto disease other than osteoarthritis, or the participant has rapidly progressingosteoarthritis (RPOA) Type I or Type II.

• The participant has significant malalignment of anatomical axis (medial angle formedby the femur and tibia) of the target knee (varus >10, valgus >10) by X-ray asassessed by independent Central Readers at Screening Visit.

• The participant has other conditions that could affect trial endpoint assessments ofthe index knee.

• The participant has current clinically significant disease(s) or condition(s) thatmay affect efficacy or safety assessments, or any other reason which, in theinvestigator's opinion, may preclude the participant's participation for the fullduration of the trial.

• The participant has a history of hypersensitivity to resiniferatoxin (RTX) or anysimilar component (capsaicin, chili peppers).

• The participant is currently participating or was participating in anotherinvestigational drug trial within 3 months prior to the Screening Visit.

• The participant is an employee of the investigator or trial site, with directinvolvement in the proposed trial or other trials under the direction of thatinvestigator or trial site or is a family member of the employees or theinvestigator.