TABLE 2.

Summary of treatment‐emergent adverse events.

Adverse events, n (%) a	Part I				Part II
	GFH312		Placebo		GFH312		Placebo
	(N = 38)		(N = 14)		(N = 19)		(N = 5)
	Any grade	Grade 2	Any grade	Grade 2	Any grade	Grade 2	Any grade	Grade 2
Any TEAEs	16 (42.1%)	0	6 (42.9%)	0	12 (63.2%)	3 (15.8%)	2 (40.0%)	0
TEAEs which occurred in ≥2 subjects in GFH312 group or TEAEs with severity of grade 2
Headache	3 (7.9%)	0	1 (7.1%)	0	4 (21.1%)	0	1 (20.0%)	0
Procedural pain	3 (7.9%)	0	1 (7.1%)	0	2 (10.5%)	0	1 (20.0%)	0
Muscle twitching	2 (5.3%)	0	1 (7.1%)	0	0	0	1 (20.0%)	0
Post‐procedural complication	0	0	1 (7.1%)	0	2 (10.5%)	0	0	0
Nausea	0	0	0	0	2 (10.5%)	0	0	0
Back pain	0	0	0	0	2 (10.5%)	1 (5.3%)	0	0
Positional vertigo	0	0	0	0	1 (5.3%)	1 (5.3%)	0	0
Blood creatinine increased	0	0	0	0	1 (5.3%)	1 (5.3%)	0	0
Treatment‐related TEAEs
Any TEAEs	2 (5.3%)	0	2 (14.3%)	0	4 (21.1%)	1 (5.3%)	1 (20.0%)	0
Diarrhea	0	0	1 (7.1%)	0	0	0	0	0
Muscle twitching	1 (2.6%)	0	1 (7.1%)	0	0	0	1 (20.0%)	0
Headache	1 (2.6%)	0	0	0	3 (15.8%)	0	0	0
Blood creatinine increased	0	0	0	0	1 (5.3%)	1 (5.3%)	0	0

Note: TEAEs are defined as adverse events that occurred following the first administration of study medication.

Abbreviation: TEAE, treatment‐emergent adverse event.

^a No ≥grade 3 adverse events were observed in the study.